OrsoBio announces Phase I results for TLC-2716 metabolic therapy

OrsoBio published Phase I data for TLC-2716 in Nature Medicine showing favourable safety and dose-dependent lipid reductions in healthy volunteers, and the drug is now being tested in a Phase IIa trial for MASLD and severe hypertriglyceridemia with final data expected by mid-2026.

OrsoBio has published Phase I clinical trial results for TLC-2716 in Nature Medicine and is continuing clinical evaluation in patients. TLC-2716 is an oral, liver-targeted inverse agonist of Liver X Receptor (LXR) developed for obesity-related and metabolic disorders. The Phase I trial in healthy volunteers reported favourable safety and reductions in multiple atherogenic lipid parameters. The company has started a Phase IIa trial in people with metabolic dysfunction-associated steatotic liver disease (MASLD) and severe hypertriglyceridemia (SHTG), with final data expected by mid-2026. Key findings: - The Phase I results were published in Nature Medicine and showed a favourable safety profile alongside robust lipid-lowering effects in healthy volunteers. - The placebo-controlled, double-blind, randomized Phase I trial enrolled 100 healthy participants and evaluated pharmacodynamics, pharmacokinetics, tolerability, and safety over 14 days, reporting dose-dependent lipid reductions and no serious adverse events. - Preclinical studies in dysmetabolic rodent models, non-human primates, and human liver organoids produced results consistent with the human data, indicating translation of liver-restricted LXR inhibition from lab models to people. - TLC-2716 is designed to act on hepatic LXR to modulate triglycerides and cholesterol through mechanisms including suppression of hepatic de novo lipogenesis and enhanced clearance of triglyceride-rich lipoproteins. - The ongoing Phase IIa trial targets patients with MASLD and SHTG; these conditions are reported to affect more than 80 million Americans, and final Phase IIa data are expected by mid-2026. Summary: Phase I data for TLC-2716 showed favourable safety and dose-dependent reductions in atherogenic lipids in healthy volunteers, findings that aligned with prior preclinical work. The program has advanced into Phase IIa testing in MASLD and severe hypertriglyceridemia, with final data due by mid-2026.